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RSS FeedPosted by Michael Wonder on 10 Dec 2020
Valeo Pharma announces Health Canada approval for Redesca and Redesca Hp
9 December 2020 - Valeo Pharma announced today that Health Canada has issued a Notice of Compliance for Redesca and ...
Posted by Michael Wonder on 09 Dec 2020
ReGelTec receives FDA breakthrough designation for its Hydrafil system
9 December 2020 - ReGelTec announced today that it has received breakthrough device designation from the Center for Devices and Radiological ...
Posted by Michael Wonder on 09 Dec 2020
Amgen's sotorasib granted breakthrough therapy designation for advanced or metastatic non-small cell lung cancer patients with KRAS G12C mutation
8 December 2020 - Sotorasib also accepted into FDA's Real-Time Oncology Review pilot program. ...
Posted by Michael Wonder on 09 Dec 2020
Canada health regulator approves Pfizer's COVID-19 vaccine
10 December 2020 - Canada’s health regulator has approved Pfizer’s COVID-19 vaccine. ...
Posted by Michael Wonder on 09 Dec 2020
COVID-19 vaccine trial deaths were not related to treatment: Pfizer
9 December 2020 - Two people who received Pfizer’s experimental COVID-19 vaccine died during clinical trials, but the pharma giant says ...
Posted by Michael Wonder on 09 Dec 2020
Blunders eroded U.S. confidence in early vaccine front-runner
8 December 2020 - The Oxford-AstraZeneca effort held great promise to help arrest the pandemic. But a series of miscues caused ...
Posted by Michael Wonder on 09 Dec 2020
Albireo submits for U.S. FDA and EMA product approval of once daily odevixibat for PFIC
8 December 2020 - Data on PFIC types 1, 2, 3 submitted to support use across a wide range of patients. ...
Posted by Michael Wonder on 09 Dec 2020
US FDA accepts for priority review the biologics license application for Pfizer’s investigational 20 valent pneumococcal conjugate vaccine for adults 18 years of age and older
8 December 2020 - If approved, the vaccine will help protect adults against 20 serotypes responsible for the majority of invasive ...
Posted by Michael Wonder on 09 Dec 2020
First coronavirus vaccine shots could be doled out in Canada next week
7 December 2020 - A select few Canadians could receive the country’s first coronavirus vaccine shots as early as next ...
Posted by Michael Wonder on 09 Dec 2020
Switzerland secures three million doses of Pfizer/BioNTech vaccine
7 December 2020 - Switzerland has signed an agreement with a third manufacturer of COVID-19 vaccines for three million doses. ...
Posted by Michael Wonder on 09 Dec 2020
Even before year end, 2020's new drug approvals match FDA's 2019 stats
7 December 2020 - The US FDA has kept its new drug approvals for 2020 on track to match or ...
Posted by Michael Wonder on 08 Dec 2020
Trump Administration passed on chance to secure more of Pfizer vaccine
7 December 2020 - The pharmaceutical company offered the government a chance to lock in additional supplies before its vaccine was ...
Posted by Michael Wonder on 08 Dec 2020
Telix granted TGA priority review for prostate cancer imaging
7 December 2020 - Telix announces today that the Company’s preliminary application to the TGA for TLX591-CDx was made at ...
Posted by Michael Wonder on 08 Dec 2020
Carlsmed aprevo granted unprecedented decision by FDA
8 December 2020 - -Carlsmed today announced it has been granted 510(k) clearance and breakthrough device designation by the FDA for ...
Posted by Michael Wonder on 08 Dec 2020
Turning Point Therapeutics granted FDA breakthrough therapy designation for repotrectinib treatment in patients with ROS1 positive metastatic non-small cell lung cancer who have not been treated with a ROS1 tyrosine kinase inhibitor
8 December 2020 - Updated data from TRIDENT-1 study in tyrosine kinase inhibitor naïve patients with ROS1 positive non-small cell lung ...